AO Operator

Philogen S.p.A.; Siena; In loco; EUR 25.000 - 35.000; Tempo pieno

Descrizione del lavoro

Philogen S.p.A. is seeking an Aseptic Filling Operator to join their team in Siena, Italy. This role involves performing aseptic filling operations in cleanroom environments while ensuring compliance with GMP regulations. The ideal candidate will have experience in sterile manufacturing, strong attention to detail, and be proficient in aseptic gowning procedures. Join a cutting-edge biopharmaceutical company dedicated to innovation and career development.

Servizi

Fixed-term contract with compensation based on experience

Ongoing training and career development

Competenze

• At least 1 year of experience in sterile or aseptic manufacturing environments.
• Strong knowledge of GMP principles and Annex 1 (EudraLex Vol. 4).
• Familiarity with isolator-based operations and cleanroom dynamics.

Mansioni

• Performing aseptic filling operations inside isolators.
• Handling materials through VPHP-decontaminated pass-boxes.
• Completing GMP documentation accurately.

Conoscenze

Attention to Detail

Team Collaboration

Flexibility

Proactivity

English Proficiency

Descrizione del lavoro

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Philogen S.p.A., an Italian biotechnology company at the forefront of developing and manufacturing innovative biopharmaceuticals in oncology, is looking for a new team member to join the Aseptic Operations department as an Aseptic Filling Operator.

Main Responsibilities:

The selected candidate will be involved in aseptic filling operations within classified cleanroom environments, specifically:

• Performing aseptic filling operations inside isolators (Grade A), in accordance with GMP and internal SOPs.
• Handling materials and components through VPHP-decontaminated pass-boxes and pass-through autoclaves.
• Performing manual visual inspection of finished drug products.
• Participating in gowning and entry procedures for classified areas, in compliance with aseptic gowning requirements and Annex 1 of EudraLex Volume 4.
• Supporting preparation and handling of primary packaging components (vials, stoppers, flip-off caps).
• Assisting in line clearance activities and preparation of isolators prior to batch execution.
• Ensuring accurate completion of GMP documentation (batch records, logbooks, forms, etc.).

Required Qualifications

• At least 1 year of experience in sterile or aseptic manufacturing environments.
• Strong knowledge of GMP principles and Annex 1 (EudraLex Vol. 4).
• Familiarity with isolator-based operations, Grade A environments, and cleanroom dynamics.
• Proficiency in aseptic gowning procedures.
• Competence in handling VPHP pass-boxes, pass-through autoclaves, and material decontamination techniques.
• Good understanding of primary packaging components. Experience in secondary packaging is considered a plus.
• Basic knowledge of written English

Soft Skills

• High attention to detail and strong sense of responsibility.
• Teamwork mindset and ability to operate in regulated environments.
• Flexibility, proactivity, and ability to meet strict deadlines.

What We Offer

• Fixed-term contract, with compensation based on experience.
• Opportunity to join a highly qualified team in a cutting-edge biopharmaceutical manufacturing environment.
• Ongoing training and career development in a fully GMP-compliant facility.

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Full-time

Job function

• Job function

  Production

• Industries

  Pharmaceutical Manufacturing

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